Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

Refractive Ametropia Clinical Trial

Official title:

Dispensing Evaluation of Lens Comfort and Subjective Vision of an Etafilcon A With Print and PVP Lens for Dark Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484054
• Other study ID #: CR-005128
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate and compare the performance of a new contact lens to a marketed contact lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

Inclusion Criteria:

• The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.

• The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).

• The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.

• The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.

• The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.

• The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D.

• Any cylinder power must be:<=0.75D.

• The subject must have visual acuity best correctable to 20/25 or better for each eye.

• The subject must have normal eyes (no ocular medications or ocular infection of any type).

• The subject must read and sign the Statement of Informed Consent.

• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

• Ocular or systemic allergies or disease which might interfere with contact lens wear.

• Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.

• Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.

• Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.

• Any ocular infection.

• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

• Any color deficiencies (color blindness) - to the best of the subject's knowledge.

• Pregnancy or lactation.

• Diabetes.

• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).

• Habitual contact lens type is toric, multifocal, or is worn as extended wear.

• Subject presents with one dark iris color and one light iris color

• Subject has heterochromia iridis (a difference in color between parts of one iris)

• The subject is an employee or family member of the clinical study site.

Related Conditions & MeSH terms

• Refractive Ametropia
• Refractive Errors

Intervention

Device:
• etafilcon A with print and PVP for dark eyes (EAPVPDE)
A daily disposable contact lens
• etafilcon A control lens (EADE)
A marketed daily disposable contact lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire	The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120.	After 7 to 9 days of lens wear
Primary	Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire	The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.	After 7 to 9 days of lens wear
Primary	Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire	The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.	After 7 to 9 days of lens wear